[Senate Hearing 112-175]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 112-175



                               before the


                                 of the

                       COMMITTEE ON THE JUDICIARY
                          UNITED STATES SENATE

                      ONE HUNDRED TWELFTH CONGRESS

                             FIRST SESSION


                              MAY 24, 2011


                          Serial No. J-112-23


         Printed for the use of the Committee on the Judiciary

71-663                    WASHINGTON : 2012
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                       COMMITTEE ON THE JUDICIARY

                  PATRICK J. LEAHY, Vermont, Chairman
HERB KOHL, Wisconsin                 CHUCK GRASSLEY, Iowa
DIANNE FEINSTEIN, California         ORRIN G. HATCH, Utah
CHUCK SCHUMER, New York              JON KYL, Arizona
DICK DURBIN, Illinois                JEFF SESSIONS, Alabama
AMY KLOBUCHAR, Minnesota             JOHN CORNYN, Texas
AL FRANKEN, Minnesota                MICHAEL S. LEE, Utah
CHRISTOPHER A. COONS, Delaware       TOM COBURN, Oklahoma
            Bruce A. Cohen, Chief Counsel and Staff Director
        Kolan Davis, Republican Chief Counsel and Staff Director

                  Subcommittee on Crime and Terrorism

               SHELDON WHITEHOUSE, Rhode Island, Chairman
HERB KOHL, Wisconsin                 JON KYL, Arizona
DIANNE FEINSTEIN, California         ORRIN G. HATCH, Utah
DICK DURBIN, Illinois                JEFF SESSIONS, Alabama
AMY KLOBUCHAR, Minnesota             LINDSEY GRAHAM, South Carolina
                Stephen Lilley, Democratic Chief Counsel
               Stephen Higgins, Republican Chief Counsel

                            C O N T E N T S




Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont.   176
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode 
  Island.........................................................     1


Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio.......     3
Eadie, John L., Director, Prescription Monitoring Program Center 
  of Excellence, Brandeis University, Waltham, Massaschusetts....    18
Hosley, Laura, Manager, Community Prevention, Rhode Island 
  Student Assistance Services, Warwick, Rhode Island.............    16
Kerlikowske, R. Gil, Director, White House, Office of National 
  Drug Control Policy, Washington, DC............................     5
Leonhart, Michele M., Administrator, Drug Enforcement 
  Administration, Washington, DC.................................     7

                         QUESTIONS AND ANSWERS

Responses of R. Gil Kerlikowske to questions submitted by Senator 
  Schumer........................................................    27
Responses of Michele M. Leonhart to questions submitted by 
  Senator Schumer................................................    32

                       SUBMISSIONS FOR THE RECORD

American Academy of Pain Medicine (AAPM), Perry G. Fine, 
  President, Glenview, Illinois, May 20, 2011 letter.............    36
American Pain Foundation, Scott M. Fishman, President and Chair, 
  Baltimore, MD, May 23, 2011, letter............................    39
American Society of Interventional Pain Physicians (ASIPP), 
  Paducah, Kentucky, statement...................................    41
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of 
  Pennsylvania, statement........................................   112
Chaudhry, Humayun J., President and Chief Executive Officer, 
  Federation of State Medical Boards, statement..................   113
Dean, General Arthur T., U.S. Army, (retired), Chairman and CEO, 
  Community Anti-Drug Coalitions of America, Alexandria, 
  Virginia, statement............................................   118
Eadie, John L., Director, Prescription Monitoring Program Center 
  of Excellence, Brandeis University, Waltham, Massaschusetts, 
  statement......................................................   137
Gressitt, Stevan, Founding Director, International Institute for 
  Pharmaceutical Safety, Portland, Maine, statement..............   146
Hosley, Laura, Manager, Community Prevention, Rhode Island 
  Student Assistance Services, Warwick, Rhode Island, statement..   159
Kerlikowske, R. Gil, Director, White House, Office of National 
  Drug Control Policy, Washington, DC, statement.................   169
Leonhart, Michele M., Administrator, Drug Enforcement 
  Administration, Washington, DC, statement......................   177
National Community Pharmacists Association (NCPA), Alexandria, 
  Virginia, statement............................................   190
Pain Care Coalition, Edward Michna, Chair, Washington, DC, May 
  20, 2011, letter...............................................   193
Pasierb, Steve, President and CEO, The Partnership at 
  Drugfree.org, New York, New York, statement....................   201
Rockefeller, Hon. Jay, a U.S. Senator from the State of West 
  Virginia, statement............................................   208
Kimberly Walsh, Deputy Commissioner, State of West Virginia, 
  Department of Health and Human Resources, Charleston, West 
  Virginia, May 24, 2011, letter.................................   210



                         TUESDAY, MAY 24, 2011

                               U.S. Senate,
               Subcommittee on Crime and Terrorism,
                                Committee on the Judiciary,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 9:04 a.m., in 
room SD-226, Dirksen Senate Office Building, Hon. Sheldon 
Whitehouse, Chairman of the Subcommittee, presiding.
    Present: Senators Whitehouse, Klobuchar, and Blumenthal.


    Chairman Whitehouse. The hearing will come to order. This 
morning's hearing considers a topic that is extremely important 
to the health and safety of our kids, of our families, and of 
our communities, and that is, ``Responding to the Prescription 
Drug Epidemic: Strategies for Reducing Abuse, Misuse, 
Diversion, and Fraud.''
    Used properly, under a physician's direction, pain 
relievers and other prescription drugs bring much-needed 
comfort to Americans. But their abuse poses a serious and 
growing threat to our communities and young people. In 2009, 
approximately 7 million Americans reported misuse of 
prescription drugs. The problem is particularly acute among 
teenagers. Prescription drugs are the second most abused 
category of drugs among our Nation's young people, and six of 
the top ten abused substances among high school seniors are 
prescription drugs.
    Prescription drug abuse is extremely dangerous. Over the 
last 5 years, emergency room visits involving improper use of 
pharmaceuticals more than doubled. Too often, the consequences 
were deadly. According to the CDC, drug-related poisonings are 
now the leading cause of death due to unintentional injuries in 
my home State of Rhode Island and in 16 other States, greater 
even than motor vehicle accidents.
    Diversion and abuse of prescription drugs can also impose 
significant financial costs on our health care system through 
emergency room visits and treatment of medical complications. 
We pay for that through higher private insurance premiums and 
higher Medicare and other public health costs.
    The ever-growing epidemic of prescription drug abuse 
demands sustained attention from law enforcement, health care 
professionals, and Congress. It poses challenges similar to 
those faced from other illegal drugs. As with illegal drugs, 
for instance, large-scale criminal networks have developed for 
the diversion and distribution of prescription drugs.
    However, there are unique challenges in the prescription 
drug context. These drugs can be readily available in our 
homes, giving teens easy and direct access. Approximately 70 
percent of people aged 12 or older who used prescription pain 
relievers non-medically in 2009 got them from a friend or 
    Furthermore, education about the threat of prescription 
drugs is more difficult because these legal drugs have an 
important medical purpose, are prescribed by physicians, and 
come from pharmacies. Teens are too often unaware of the 
dangers of misuse and abuse.
    The special characteristics of prescription drugs demand a 
multi-pronged strategy for reducing wrongful use. This strategy 
should include educating prescribers and patients about 
responsible uses of these drugs, recognizing signs of abuse, 
providing appropriate treatments and interventions, and 
deploying appropriate law enforcement resources.
    Electronic information-sharing systems, such as the 
prescription drug monitoring programs authorized in 43 States, 
are promising tools for identifying pill mills and doctor 
shoppers. I was pleased to get bipartisan legislation passed 
last year allowing the Government to perform sophisticated 
analyses of Medicare data in order to avoid paying fraudulent 
claims and to give law enforcement tools for investigating 
criminal fraud. There are analogous ways to strengthen 
prescription monitoring programs so that they have more 
complete prescription data, use advanced analysis to identify 
diversion or abuse, and better allow prescribers, law 
enforcement, and others to address these problems.
    E-prescribing can also play a valuable role, limiting 
diversion, fraud, and medical mistakes by reducing 
opportunities for forgery and error. I am pleased that Rhode 
Island is a national leader in e-prescribing. We can combine 
the advantages of e-prescribing and of prescription monitoring 
programs to help physicians recognize early patterns of abuse.
    Today's hearing seeks to advance these goals. I welcome our 
witnesses from the Office of National Drug Control Policy and 
the Drug Enforcement Agency, as well as from Brandeis 
University and my home State of Rhode Island.
    I congratulate the Obama administration on the release of 
their proposals for responding to America's prescription drug 
abuse crisis. I look forward to working with the 
administration, Chairman Leahy, Ranking Member Kyl, and other 
Senators from both sides of the aisle on legislation to protect 
against prescription drug abuse.
    I saw Senator Kyl this morning, and he indicated that he 
may not be able to attend the hearing today. His schedule has 
been, I guess, a little bit tumultuous, and if he can, of 
course, I will recognize him. But if he does not, I have been 
instructed to proceed.
    We have Senator Sherrod Brown of Ohio here to kick off the 
hearing. Senator Brown has taken a keen interest in this issue, 
and we look forward to his statement. Thank you, Senator Brown.

                            OF OHIO

    Senator Brown. Thank you, Chairman Whitehouse, for allowing 
me to testify today and for your leadership on this important 
Subcommittee on Crime and Terrorism.
    Chairman Whitehouse and I served together on the Health, 
Education, Labor, and Pension Committee where we worked closely 
together on the Patient Protection and Affordable Care Act, and 
throughout our time in the Senate, I valued his expertise on 
the connections between our health care and our legal systems.
    Today's hearing is an example of that connection, how the 
rampant abuse and trafficking of prescription drugs pose both a 
public health threat and a law enforcement threat. In recent 
years, more Ohioans have died from prescription drug overdoses 
than from car accidents. In 2008, statistics show that 
oxycodone and Percocet and other prescription drugs caused more 
overdoses in Ohio that year than heroin and cocaine combined. 
Prescription pain medications such as OxyContin are largely 
responsible for increasing overdoses and deaths in my State and 
across the country. Simply put, prescription drug abuse, as the 
Chairman said, is the fastest-growing drug problem in the 
    Almost every day in Ohio, there is a reported story of a 
child lost to prescription drug abuse or neighborhoods 
harboring its illicit trade. In southeast Ohio, the most rural 
part of the State, it is particularly tragic. Old factory towns 
and rural communities have become havens for prescription drug 
abuse. These stories, of course, are not limited to Ohio and 
Rhode Island. Across the country communities are struggling to 
find ways to respond and to develop strategies to reduce the 
diversion and abuse of prescription drugs.
    Last year, I convened a first of its kind roundtable in 
southern Ohio with Federal and local law enforcement, community 
activists, elected officials, drug treatment leaders, and 
members from the medical community. They raised a concern with 
criminal manipulation of Ohio's Medicaid program, which spends 
upwards of $820 million on prescription medicines. While most 
prescription pain medicines are used as prescribed, as the 
Chairman pointed out, and they are valuable, some criminals 
defraud the Medicaid system and fleece Ohio taxpayers by 
acquiring multiple prescriptions and filling them at multiple 
    A case of criminals defrauding taxpayers in the Medicaid 
system to sell and divert prescription drugs becomes a one-two 
punch in the stomach to the system. That is why last month I 
introduced the Stop Trafficking of Pills Act, which would 
establish a Medicaid lock-in program for Ohio and nationwide to 
crack down on the use of Medicaid cards to obtain and illegally 
resell prescription drugs. The bill would prevent prescription 
drug abusers from acquiring excess prescription drugs which 
they may abuse or illegally resell by barring them from 
visiting multiple doctors and pharmacies. Nearly 20 States 
already have something similar to the Medicaid lock-in program. 
South Carolina's Medicaid lock-in pilot program targeted at 
high-use beneficiaries spurred a 43-percent decrease in the 
total number of prescribed prescription pain medications.
    Consider Scioto County on the Ohio River in southern Ohio. 
In this Ohio River town, prescription drugs cause nine of every 
ten fatal drug overdoses. In nearly two-thirds of these cases, 
the individuals involved did not have prescriptions themselves, 
indicating, of course, they in all likelihood obtained the 
drugs illegally. An investigation by the GAO, which audited the 
Medicaid program of the five largest States, found 65,000 cases 
in which Medicaid beneficiaries visited six or more doctors and 
up to 46 different pharmacies to acquire these prescriptions. 
This same report found approximately 800 prescriptions written 
for dead patients and 1,200 prescriptions written by dead 
    Under a Medicaid lock-in program, States would identify 
high-risk prescription users, those who are receiving an 
excessive amount of prescription drugs or those who have been 
convicted of a drug-related offense. These high-risk 
prescription drug users would be placed in the program and 
assigned one physician and one pharmacy. It would mean no more 
doctor shopping, no more pharmacy hopping.
    States would identify prescription drugs that are dispensed 
under Medicaid and that present a high risk of overutilization. 
The legislation requires the Federal Government to set up a 
similar lock-in program for Medicare, where the abuse is there 
but obviously not as high. Prescription drug abuse in Ohio and 
our Nation needs to be treated like the epidemic it is.
    Chairman Whitehouse has been a leader on this issue, urging 
the DEA to implement electronic prescribing for controlled 
substances and calling for strong prescription drug monitoring 
    Today's witnesses will describe the administration's 
comprehensive prescription drug strategy and ways FDA can crack 
down on the abuse, and community activists will describe the 
victims and families whom they represent, offering the stories 
behind the statistics and policies being discussed.
    From the policies to the stories, it is clear prescription 
drug abuse knows no party lines. It is clear it is an issue of 
life or death in too many parts of our Nation, at least in my 
State especially in rural areas, which have experienced 
terrible job loss and economic hardship for hundreds of 
thousands of families.
    I will stop there. I thank the Chairman for allowing me to 
    Chairman Whitehouse. Senator Brown, I appreciate very much 
your energy and your leadership on this issue, both here in 
Washington and in your home State of Ohio. It seems that Ohio 
and Rhode Island have a lot in common on this issue, and I look 
forward to continuing to work with you as you go forward. I 
particularly appreciate that, as busy as your schedule is, you 
took the time out this morning to come to this Committee, of 
which you are not a member, to make sure that your voice was 
heard here, and I am very grateful to you for that.
    I know your schedule commands you to be elsewhere, so thank 
you very much for taking the trouble.
    Chairman Whitehouse. Now I will ask our first panel, Hon. 
Gil Kerlikowske and Hon. Michele Leonhart, to come forward. Let 
me ask you to stand and be sworn. Do you affirm that the 
testimony you are about to give before the Committee will be 
the truth, the whole truth, and nothing but the truth?
    Mr. Kerlikowske. I do.
    Ms. Leonhart. I do.
    Chairman Whitehouse. Thank you. Please be seated.
    Thank you both for being here. It is an impressive turnout. 
And for those of you who do not know our witnesses, Gil 
Kerlikowske is the Director of the White House Office of 
National Drug Control Policy. Director Kerlikowske served as 
the chief of police for Seattle, Washington; was Deputy 
Director for the U.S. Department of Justice Office of 
Community-Oriented Policing Services; was police commissioner 
of Buffalo, New York; and served in the St. Petersburg, 
Florida, police department. He has been elected twice to be 
president of the Major Cities Chief, and he has received 
numerous awards and recognition for leadership, innovation, and 
community service.
    He is joined by Michele Leonhart, who is Administrator of 
the Drug Enforcement Administration. Confirmed in December 
2010, she had been the Acting Administrator since 2007 and 
Deputy Administrator since 2004. As a career DEA special agent, 
Ms. Leonhart held several key positions as she moved through 
the ranks of DEA, including as assistant special agent in 
charge of the Los Angeles Field Division. She has received 
numerous awards, including the Rank of Distinguished Executive 
in 2004, and the Presidential Rank Award for Meritorious 
Service in 2005 and 2000.
    It is truly our privilege to have these two witnesses here, 
and why don't we go across the table. We will start with Mr. 
Kerlikowske. Please proceed with your statements.


    Mr. Kerlikowske. Chairman Whitehouse, thank you very much 
for this opportunity to address the important issue of 
prescription drug abuse in our country, and I am very grateful 
for the Committee's attention to this topic. Prescription drug 
abuse has been a major focus at ONDCP since my confirmation, 
and I have directed the National Drug Control Program agencies 
to address this epidemic in our country.
    I have the responsibility to raise public awareness, 
coordinate Federal activities, and take action on drug issues 
that affect our Nation. The efforts that we have taken are 
balanced. They incorporate new research and evidence-based 
approaches to address drug use and its consequences.
    Prescription drug abuse is the fastest-growing drug problem 
in the United States. It is categorized as a public health 
epidemic by the Centers for Disease Control and Prevention. The 
number of individuals who for the first time consumed 
prescription drugs for a non-medical purpose was similar to the 
number of first-time marijuana users. We have also seen a 
fourfold increase in addiction treatment admissions for 
individuals primarily abusing prescription painkillers from 
1997 to 2007.
    Even more alarming is the fact that about 28,000 Americans 
have died from unintentional drug overdoses in 2007, and 
prescription drugs, particularly the opioid painkillers, are 
considered major contributors to the total number of drug 
deaths. And we believe there are two unique reasons for the 
growth in prescription drug abuse: easy accessibility to the 
drugs and the diminished perception of risk. A comprehensive 
approach is required to address this epidemic. It is important 
to balance prevention, education, and enforcement with the need 
for legitimate access to controlled substances.
    The administration has created an inclusive Prescription 
Drug Abuse Prevention Plan that brings together Federal, State, 
local, and tribal groups to reduce prescription drug diversion 
and abuse. The plan expands upon the administration's National 
Drug Control Strategy and has four major areas.
    The first is education. Mandatory prescriber education as 
well as patient and parent education is essential. Sixty-nine 
percent of narcotic analgesics are distributed in primary care 
offices and emergency departments. In addition, we want to make 
sure that patients and parents are fully aware of the dangers 
and the prevalence of prescription drug abuse and that they are 
educated about the safe use and proper storage and disposal of 
these medications. The FDA is implementing a Risk Evaluation 
and Mitigation Strategy plan that requires manufacturers of 
long-acting and extended-release opioids to ensure that 
training is provided to prescribers.
    The second part of our plan includes that each State have a 
Prescription Drug Monitoring Program (PDMP), and Senator Brown 
mentioned the importance of those, and I know you have another 
witness that will be talking about those. But we are strongly 
supportive of those and that they have interoperability and 
that they be used by all of the prescribers.
    We have also made significant investments in health 
information technology and continue to work with HHS 
particularly on health information exchanges. Opportunities 
include identifying ways to incorporate real-time PDMP data at 
the point of care and dispensing.
    The third part of the plan calls for proper medication 
disposal. Unused medications that sit in our medicine cabinets 
are falling into the wrong hands, and by creating a method for 
proper disposal of expired or unused prescription drugs, we 
will benefit public health, public safety, and the environment. 
Passage of the Secure and Responsible Drug Disposal Act in 2010 
was an important step forward in our efforts to make 
prescription drug disposal more accessible to individuals and 
to reduce the supply of drugs available. A drug disposal 
program has to be easily accessible to the public, 
environmentally friendly, cost-effective, and the cost burden 
should not be placed on consumers.
    The last part of the plan is smart law enforcement. You 
have the expert sitting to my left to talk about that, but our 
main effort will be, as they have already done with the DEA's 
comprehensive work on pill mills, to address the issue of 
doctors who overprescribe, and of course, PDMPs help with 
doctor shopping. Our office, ONDCP, supports the HIDTAs, the 
High-Intensity Drug-Trafficking Areas, and we want to make sure 
that local law enforcement, with the cooperation of DEA, have 
the support that they need to understand these complex 
investigations and do a better job of bringing drug dealers to 
    In closing, I want to thank all of my colleagues in the 
executive branch, but particularly we could not be effective in 
any of these areas without the support of Congress.
    [The prepared statement of Mr. Kerlikowske appears as a 
submission for the record.]
    Chairman Whitehouse. Thank you, Director Kerlikowske.
    Director Leonhart.


    Ms. Leonhart. Chairman Whitehouse, Senator Klobuchar, thank 
you for the opportunity to discuss the growing epidemic of 
prescription drug abuse and the critical role of the Drug 
Enforcement Administration in the enforcement of our Nation's 
drug laws and regulations.
    The diversion and abuse of pharmaceutical controlled 
substances is a significant and growing problem in the United 
States. Every leading indicator shows increases over relatively 
short periods of time in the use and abuse of these drugs. Pain 
clinics have emerged as a major source of controlled substances 
for non-legitimate medical purposes. DEA and other Federal, 
State, and local law enforcement agencies have developed great 
working relationships and continuously coordinate efforts to 
combat this emerging threat.
    Federal administrative and criminal actions against a 
physician with controlled substance privileges is rare. 
However, such actions are warranted when a physician is issuing 
controlled substance prescriptions for an illegitimate purpose 
and operating outside the usual course of professional 
practice. And as Administrator, I have made prescription drug 
abuse a top priority.
    I am especially alarmed that another contributing factor to 
the increase in prescription drug abuse is the availability of 
these drugs in the household. In many cases, prescription drugs 
remain in household medicine cabinets well after medication 
therapy has been completed, thus providing easy access to non-
medical users for abuse, accidental ingestion, or illegal 
distribution for profit. And the 2010 Partnership Attitude 
Tracking Study, which we call PATS, noted that 51 percent of 
those surveyed believe that most teens get prescription drugs 
from their own family's medicine cabinets.
    DEA manages a robust regulatory program aimed at preventing 
and curbing diversion, all the way from the manufacturing level 
to the dispensing of these medications to patients. In working 
with Congress, DEA also obtained new authority last year to 
regulate the disposal of unused medications by ultimate users, 
thereby getting unused medications out of the household 
medicine cabinets in a lawful manner.
    DEA is working diligently to promulgate disposal 
regulations. In the interim, DEA launched a nationwide take-
back initiative in September of last year and again in April of 
this year, resulting in the combined collection of 309 tons of 
unwanted or expired medications. And DEA will continue to hold 
periodic take-back events until regulations are in place.
    DEA's obligation under the law and to the public is to 
ensure that pharmaceutical controlled substances are prescribed 
and dispensed only for legitimate medical purposes in 
accordance with the Controlled Substances Act. And by carrying 
out this obligation, DEA strives to minimize the diversion of 
pharmaceutical controlled substances for abuse while ensuring 
that such medications are fully available to patients in 
accordance with the sound medical judgments of their doctors. 
In this manner, DEA is committed to balancing the need for 
diversion control and enforcement with the need for legitimate 
access to these drugs.
    DEA closely monitors the closed system through 
recordkeeping requirements and mandatory reporting at all 
levels of the supply chain. Due to enhancements to our 
regulatory resources, controlled substance manufacturers, 
distributors, importers, exporters, and narcotic treatment 
programs are receiving more inspections and audits than ever 
before. A key component to our enhanced investigative resources 
are tactical diversion squads. These unique groups combine the 
skills of special agents, diversion investigators, and task 
force officers. These TDS groups, as we call them, are 
dedicated solely toward investigating, disrupting, and 
dismantling those individuals or organizations involved in 
diversion schemes, and as of today, DEA has 37 operational TDS 
groups. DEA plans to add 27 more over the next few years.
    One example of the effectiveness of these tactical 
diversion squads is Operation Pill Nation, which has targeted 
rogue pain clinics in South Florida since February of 2010 and 
culminated in a series of major takedowns this past February. 
This led to 32 arrests, including 12 doctors and 5 pain clinic 
owners, and DEA also immediately suspended 63 DEA registration 
numbers and issued orders to show cause on 6 DEA registrations, 
which resulted in the surrender of 29 DEA registration numbers. 
And this caused a ripple effect throughout South Florida and 
resulted in 54 more registration numbers being surrendered.
    DEA recognizes that it cannot solve this problem alone, and 
DEA is working with our Federal, State and local, and private 
sector partners as a part of this administration's 
comprehensive approach to combating prescription drug abuse.
    Many States also have adopted prescription drug monitoring 
programs, which are deemed to be a valuable tool in curbing 
diversion. The administration supports establishment of these 
programs in every State because PDMPs help cut down on 
prescription fraud and doctor shopping by giving physicians and 
pharmacists more complete information about a patient's 
prescriptions for controlled substances.
    In closing, prescription drug abuse is a dangerous threat, 
and DEA is determined to be a part of the solution. And with 
your support and that of our partners, I know we will continue 
to make a positive difference in the lives of millions of 
Americans and communities across the Nation. So I thank you for 
the opportunity to appear here today, and I look forward to 
answering your questions.
    [The prepared statement of Ms. Leonhart appears as a 
submission for the record.]
    Chairman Whitehouse. Thank you, Ms. Leonhart.
    Chairman Leahy could not be here today, but he has offered 
a statement for the record reflecting, among other things, 
observations we got, Director Kerlikowske and I, with the 
Chairman at the hearing that he held up in Vermont last year 
with all of us together. And without objection, I will add that 
to the record of this hearing.
    [The prepared statement of Chairman Leahy appears as a 
submission for the record.]
    Chairman Whitehouse. I have a couple of questions. I think 
I will probably pass on the drug disposal questions because we 
are joined by Senator Klobuchar, who was the author of the 
Secure and Responsible Drug Disposal Act of 2010 that was 
mentioned in the testimony. But I do want to mention on that 
that I was in Rhode Island the other day at the Narragansett 
Bay Commission's Bucklin Point Treatment Facility, and they are 
actually seeing effects from pharmaceuticals that are discarded 
down the drain out in the environment as they come through the 
treatment system and go out in that case into the river and 
then on down to the bay. So it is not a solution necessarily to 
have people dispose of this by throwing it down the drain. We 
really have to improve on that, and I suspect she will urge you 
to move those regulations with some degree of dispatch.
    As you know, we have had a long battle over the e-
prescribing regulations. I think that has been 3 years from 
when we had the first hearing, and your predecessors at DEA sat 
next to people from HHS and had completely different views of 
the world, and in the same administration. And I gather that 
that has all been worked through, but if you could bring me up 
to date on where we are under the interim final rule in terms 
of actual deployment and the ability to certify contractors and 
actually have e-prescribing take place in the field.
    I am assuming that you view e-prescribing as an 
investigative and awareness asset in the drug diversion 
problem, and in that frame, I would like you to let me know 
where we stand.
    Ms. Leonhart. Yes, Chairman. We do view e-prescribing as an 
important tool--a tool for law enforcement, actually. We have 
worked very hard, especially since last March when I signed the 
interim rule, which went into effect almost a year ago. June 
1st will be a year. We have been in contact with the people 
that are putting together the systems. They are moving forward. 
And we understand the first ones may be ready this summer for 
audit and then come online and be available by the end of the 
    We have looked at a number of the comments that came in. 
The interim rule is in effect now. We believe the final rule 
will be ready to go early next year, and there should be no 
reason that people should not be moving forward to implement e-
prescribing, which will help in many ways to include the 
diversion problem of prescription drugs, as well as help with 
fraud and enhance health for patients.
    Chairman Whitehouse. Is there actually e-prescribing of 
controlled pharmaceuticals under the interim final rule 
happening now? Or are people still waiting for the contractors 
to be certified so that it can actually happen? I mean, it is 
one thing to have the rule be in operation. It is another thing 
to actually have something happen in the real world. And I am 
not sure that this has actually hit the real world yet. Could 
you let me know what the status is in terms of actual flow of 
data across e-prescribing networks of controlled 
    Ms. Leonhart. Well, I can tell you it has not hit the real 
world yet, but the systems are being put in place. They first 
need to be audited. We understand one has announced called 
``Doctor First.'' It has announced that it is DEA compliant and 
is ready to move forward, and I believe it is in the auditing 
stages now and has identified over 150 different customers, and 
that will be the first one that we have heard of that will come 
online probably by the end of the year.
    Chairman Whitehouse. I am not going to remember the exact 
numbers that Senator Brown used, but he described individuals 
who had multiple prescriptions from multiple doctors and were 
using multiple pharmacies, and that is the type of thing that 
this sort of system can flag so that it does not happen, 
    Ms. Leonhart. That is correct--that with the prescription 
drug monitoring programs, we will be able to identify people 
that are doctor shopping, as you just explained.
    Chairman Whitehouse. I will now recognize Senator 
Klobuchar, author of the Secure and Responsible Drug Disposal 
Act of 2010.
    Senator Klobuchar. Thank you. You remember that name better 
than I do. That is pretty good.
    Thank you to both of our witnesses. Director Kerlikowske 
and I worked together back when he was police chief and I was 
county attorney. And then, of course, Ms. Leonhart, we have 
worked together as well, and you are from Minnesota so you can 
do no harm, as far as I am concerned.
    Senator Klobuchar. I wanted to go through--as Senator 
Whitehouse mentioned, we passed into law the Secure and 
Responsible Drug Disposal Act, something that Senator Cornyn 
and I authored, and got it through the House, and thank you for 
your help in doing that, Director Kerlikowske. And I wanted to 
find out the status of the rules. You know what this bill does, 
acknowledging that prescription drugs are the No. 2 way that 
kids can get addicted to drugs, the drugs sitting around in 
their parents' medicine cabinets. And this allows pharmacies to 
do take-back programs, more than just police departments; 
clarifies some of the details; also for long-term care 
facilities, which it turned out were flushing a lot of these 
pills down the toilet because they did not know what they could 
do legally. And I know that the regulations were included as 
part of the plan released by the White House.
    Can you give us an update on the drafting of the 
regulations? And what are some of the key issues you will be 
looking at? And what do you think the timetable will be?
    Mr. Kerlikowske. Senator, since it is in the design of the 
rulemaking, and the White House is not influencing the 
rulemaking, I would defer and ask that maybe Administrator 
Leonhart answer that question. Thank you.
    Senator Klobuchar. OK. Very good. Thank you.
    Ms. Leonhart. Senator, I want to thank you for your 
support. I am not sure that bill would have passed without your 
fine support and the support of your colleagues. It is very 
important to us. I am pleased to say that we are on track and 
hope to have a final rule by the end of the year or early next 
year. In the meantime, we have held our second take-back just 
last month, which was even more successful than the first take-
back in September.
    We held a hearing, an open forum hearing, in January and 
had over 100 witnesses provide comments and submit comments 
that we are looking at very closely. And the good news is we 
are on track to have a final rule hopefully by the end of the 
year or January or February of next year.
    Senator Klobuchar. OK. Very good. And are you working with 
various stakeholders on the rules and getting input?
    Ms. Leonhart. Absolutely. The public forum had stakeholders 
from all entities, and we have a wide range of recommendations 
and suggestions from them. And all options are on the table to 
come up with the best final rule we can get that allows for 
that safe and regular disposal.
    Senator Klobuchar. Very good, because I think that we know 
the take-back programs are great. They are becoming more and 
more popular. But to have something that would be just 
commonplace in pharmacies would be the best, and certainly 
helping all these long-term care facilities would be good as 
    I had a different kind of question, and it is about the use 
of synthetic drugs, including synthetic hallucinogens. And as 
you know, these drugs are not prescription medications, but I 
think it is clear that the abuse of these illegal drugs and 
prescription drugs are closely related. And I have a bill--
Senators Grassley and Schumer have one, on certain types of 
synthetics, and I have one based on--it is called 2C-E, 
something that actually killed a young man in Minnesota and 
almost killed a number of others at a party. And I just 
wondered if you were aware of this problem, either of you, and 
if we have your support in moving forward on this legislation.
    Ms. Leonhart. We are absolutely aware of the synthetics, 
and especially of the young man who lost his life in Minnesota 
with the use of the 2C-E compound. These are synthetics that 
are the drugs of the future. Whether it is synthetic cannabis 
or a synthetic stimulant or hallucinogen, young people are 
attracted to that, so it concerns us.
    So we support any legislation, any tools that Congress can 
put forward that will help us combat that, and know that in 
Minnesota as well as the other States where these synthetics 
have shown up, we are working with State and local law 
enforcement. We are providing technical assistance, training, 
to do whatever we can to put a stop to that.
    Senator Klobuchar. OK. Director Kerlikowske.
    Mr. Kerlikowske. And, Senator, while the process is going 
on, the legislative process, we have used the bully pulpit of 
the White House to be able to bring to a lot of people's 
attention the problems of the things such as bath salts, 
synthetic drugs, et cetera. So that has been helpful in 
alerting people to the problem, and thank you.
    Senator Klobuchar. Very good. I just think the more we can 
list some of these as clearly illegal, that helps you with your 
education process, makes parents aware of this new phenomenon 
with these drugs that I do not think anyone ever anticipated a 
decade ago.
    My last question along the lines of the tools for all of 
you to use is that the administration's plan on prescription 
drugs makes reference to the role of Congress, and if you could 
touch further on the role of Congress. Can you talk about the 
potential need for further legislation in the area of illegal 
prescription drugs? Director Kerlikowske.
    Mr. Kerlikowske. Senator, we think one of the most 
important parts of the comprehensive prescription drug plan 
will be in mandatory prescriber education. When we developed 
President Obama's National Drug Control Strategy, his direction 
to me was to make sure that the voices of people across the 
country were heard, and we did that and included discussion 
around prescription drugs and information.
    The actual prescription drug plan is more comprehensive, 
more specific, and we developed it very much in the same way--
by listening to people all over the country, particularly a 
number of prescribing physicians, whether they were in 
emergency departments or whether they were in a number of other 
locations, for instance, pain management or primary care. And 
overwhelmingly the information that was provided to me by them 
was that additional information and education about addiction, 
about dependence, about prescribing pain medications was 
important and vitally needed. And overwhelmingly they had told 
me that it should be mandatory. Although voluntary education is 
certainly something that people appreciate, and I know that 
these are physicians who are very overworked, mandatory 
prescriber education is, in my opinion, very important.
    Senator Klobuchar. All right. Thank you very much.
    Thank you, Mr. Chair.
    Chairman Whitehouse. And now we will turn to the 
distinguished Senator from Connecticut, whose many years of 
exemplary service as the Attorney General in Connecticut make 
him keenly aware of this issue. Senator Blumenthal.
    Senator Blumenthal. Thank you, Senator Whitehouse, and 
thank you for holding this hearing, and thank you especially 
for being attuned to this very, very difficult and profoundly 
important topic. And I thank you both for your great work on 
this issue.
    I want to thank you also for the recommendation from the 
White House Office of National Drug Control Policy in its plan 
to combat prescription drug abuse to recommend that the 
Secretary of Veterans Affairs share patient information on 
controlled substance prescriptions with State prescription drug 
monitoring programs, which I think is very, very important. As 
you know, the VA also supports this request. And I will be 
introducing legislation within the coming days as part of a 
comprehensive program on veterans issues to support providing 
that tool in the toolbox, so to speak.
    So I wonder if you or Director Leonhart could perhaps share 
with us and put on the record your views as to why this 
recommendation is important.
    Mr. Kerlikowske. Senator, thank you very much. I could not 
have a stronger partner than General Shinseki and the VA on 
this issue. I do not think there is anyone in this country that 
is not supportive of our active-duty military and our returning 
veterans and how they can be helped. But we also know very 
correctly that self-medication, the use of prescription drugs 
in both the active-duty military--it has been well documented--
and also returning veterans, is a significant problem. It is a 
problem for combat readiness and force readiness. It is a 
problem for local jurisdictions, particularly jurisdictions 
where National Guard returns and there may not be as large a 
military base or presence.
    Prescription drug monitoring programs that are now in 
almost every State--and not all of them active, but we are 
working to help them to become more robust--are only as 
effective as how they are used. And if you can go into a VA 
hospital and obtain prescription drugs and then go down the 
street to a private physician, and the two systems do not talk 
to each other, that is dangerous for the patient. It puts the 
physicians in a difficult position because they do not know 
about what prescriptions are being offered to that patient by a 
different physician in a different facility. And so the support 
of the VA and the support of the Department of Defense on that 
issue, so that one system can clarify and talk to each other, 
is good for our veterans and our active-duty military. And it 
is clearly a patient safety issue, and I thank you for that 
    Senator Blumenthal. Would you have anything to add, Ms. 
    Ms. Leonhart. I would add that it is a very serious 
problem: 5.3 million Americans are abusing painkillers, and 
among those 5.3 million are our veterans, especially returning 
veterans. And the leadership of Director Kerlikowske bringing 
the VA to the table has been significant and I think will in 
the end benefit all of our efforts, especially those that will 
most affect veterans. And thank you for your interest in that 
    Senator Blumenthal. It almost enables or encourages doctor 
shopping and abuse to have these two separate systems that are 
completely unlinked and simply do not communicate with each 
    How well--and I realize this is kind of an open-ended 
question, but how well are the State systems working? And do 
you note wide variation in their effectiveness? If you could 
give us a general assessment.
    Mr. Kerlikowske. There are a number of people that have 
looked at these. The CDC just recently released a report, 
although the data that they used was a bit dated. I have 
examined them and looked at them. There are some States--
particularly what is called the KASPER system in Kentucky, 
which is very forward leaning in this area, but there are 
several problems, and we have addressed those in the 
prescription drug plan. One is that they should be 
interoperable and talk to each other.
    During our 4-day trip to eastern Kentucky and also West 
Virginia, we learned that doctors would have to access multiple 
systems--those in Ohio, those in West Virginia, those in 
Kentucky--when it came to checking on patients and making sure 
that they were not overprescribing for patients who were 
seeing, in fact, other physicians. So the interoperability is 
key. The fact that it should be easy, that the information 
should be readily accessible and should be in as close to real 
time as possible, are all important efforts.
    So this is a great first step, all of the States, including 
the State of Florida, passing that legislation, moving forward, 
now making them more robust, making them used, and making them 
interoperable, are all key components of the prescription drug 
    Ms. Leonhart. I would add that we have seen some promising 
information coming from the States that actually share that 
PDMP information with law enforcement. For instance, a recent 
study showed that there were lower death rates in States that 
were sharing with law enforcement, specifically in California, 
Texas, and New York. So it is a promising tool. Good to see 
that soon there are only two States that will be without PDMPs 
or without legislation pending.
    Senator Blumenthal. Thank you very much. Thank you both for 
your great work in this area.
    Chairman Whitehouse. Just to follow up on Senator 
Blumenthal's question, have you been alerted to any desire for 
Federal legislative changes to support the State initiatives in 
prescription drug monitoring? As I understand it, the Medicare 
and Medicaid billing information, for instance, access to that 
for purposes of identifying prescription drug abuse and 
diversion is being accomplished primarily at the State level. 
Are they running into common problems that we should attend to? 
Or is the State-based process, do you think, a successful one 
in terms of something that can go forward and continue to make 
progress on its own without further Federal legislation?
    Mr. Kerlikowske. Senator, we have widely discussed at the 
different hearings and the different visits that we have had 
around the country, the issue of a national PDMP. A couple 
things came into play.
    One, the experts that have developed those systems say they 
would be very difficult to implement because of, for instance, 
just the difficulty of personal identification when it comes to 
common names across an entire Nation, an entire data base. That 
would be a problem.
    Second, that the States design these and operate these 
themselves and, therefore, they can put into place the patient 
privacy, the confidentiality guidelines that they would like, 
and also who has access to it. I think there are a number of 
best practices, and I think as the evaluation continues on, I 
am pretty hopeful that the individual States by working 
together--and, of course, your next witness is certainly 
another subject matter expert in this--can be very helpful. But 
right now I am quite satisfied with what I am seeing at the 
State level.
    Chairman Whitehouse. Do you agree, Ms. Leonhart?
    Ms. Leonhart. I do agree. I do believe that Congress could 
help, however, in the area of interoperability. And, of course, 
funding is an issue for the States moving forward with these 
    Chairman Whitehouse. Well, thank you both very much. This 
has been--do you have any further questions, Senator 
Blumenthal? Are you ready for the next panel? Should we go on? 
If you would like another round, I----
    Senator Blumenthal. I wanted to follow up on Senator 
Whitehouse's excellent question about encouraging the 
effectiveness of the drug monitoring programs, and I know that 
there is some reluctance to make it more national and impose 
kind of national requirements. But I wonder where you see the 
resistance to increasing the interoperability, which I think is 
really key. As it is in so many criminal justice information 
programs, the failure to link State systems is a major barrier. 
So I am wondering either now or if you want to think further 
about it and respond in writing or have a conversation about 
it, I would be very interested in following up on that issue.
    Mr. Kerlikowske. I know that the State of Ohio and the 
State of Kentucky have signed an interoperability agreement to 
begin sharing information. I think that shows some promise, and 
I would be happy to follow up to that question.
    Senator Blumenthal. Great. Thank you very much.
    Thank you, Mr. Chairman.
    Chairman Whitehouse. Let me thank the witnesses. Let me 
reference back to a statement that Director Kerlikowske made 
about his role as the bully pulpit at the White House on some 
of these issues, which is a role we obviously encourage. But I 
would hope that you might also be a bit of a bully pulpit 
within the White House with our friends at the Office of 
Management and Budget as these relevant rulemakings proceed. It 
has been astounding to me as a newly elected Senator to see the 
pace at which Federal rulemaking slugs forward. And while I 
think the agencies themselves are not always absolved of 
responsibility, it does seem that there is a common thread that 
things do seem to bog down at OMB. And if there is anything you 
can do to move some of these along and get OMB to expedite to 
the extent that they can, I think that would be helpful.
    I cannot tell you how long it took to get through the 
controlled pharmaceutical e-prescribing situation, and that was 
in theory with pretty much everybody on board as to the 
direction it should go. So I have become--I do not know what 
you would call it, but impatient, I guess, with the pace of 
Federal rulemaking. And you may be in a position to expedite it 
a bit, and if you can, I would urge you to do so. But I thank 
you for your dedicated efforts over many years in this area, 
and you, too, Ms. Leonhart. As Attorney General Blumenthal and 
I both know, you have people out in our streets and in the 
streets of foreign countries every day who are resourceful and 
brave, who take extraordinary risks to protect us. We have both 
had the pleasure and privilege of working with DEA agents who 
have been really among the finest Americans I have ever had the 
chance to work with. And so, I thank you for being here on 
their behalf.
    The panel is excused, and we will take a 2-minute break 
while the next panel assembles itself. Thank you both for your 
    Chairman Whitehouse. All right. If the hearing room will 
come back to order, my first order of business is to add to the 
record of this proceeding a number of items:
    First, a letter from our colleague, Senator Casey, and then 
statements from the Partnership at Drugfree.org; from the 
Community Anti-Drug Coalitions of America; from the American 
Pain Foundation; from the American Academy of Pain Medicine; 
from the International Institute of Pharmaceutical Safety; from 
the Federation of State Medical Boards; and from the American 
Society of Interventional Pain Physicians. I appreciate all of 
their statements, and they will be, without objection, added to 
the record of these proceedings.
    [The statement appears as a submission for the record.]
    Chairman Whitehouse. We now have our next panel. Our two 
witnesses are:
    First, Laura Hosley. She is manager of community prevention 
for Rhode Island Student Assistance Services. She also serves 
as coordinator of the Jamestown, Rhode Island, Prevention 
Coalition and oversees the North Kingstown, Rhode Island, drug-
free communities grant. She previously served as project 
manager at the University of Rhode Island's Cancer Prevention 
Research Center, worked as a student assistance counselor in 
Rhode Island middle and high schools, and directed a group 
home, serving individuals with mental illness and substance 
abuse problems. She has an undergraduate degree in education 
and psychology from the University of Rhode Island and a 
master's in management from Lesley University.
    She is joined on our panel today by John Eadie, who is the 
director of the Prescription Monitoring Program Center of 
Excellence at Brandeis University. He previously served as 
director of the Division of Public Health Protection in the New 
York State Department of Health from 1985 to 1995, where he 
directed the State's pharmaceutical diversion program, 
including the prescription monitoring program. He was co-
founder and president of both the Alliance of State with 
Prescription Monitoring Programs and the National Association 
of State Controlled Substances Authorities.
    If I could ask you to stand while we administer the oath. 
Do you affirm that the testimony you are about to give before 
the Committee will be the truth, the whole truth, and nothing 
but the truth, so help you God?
    Ms. Hosley. I do.
    Mr. Eadie. I do.
    Chairman Whitehouse. Please be seated.
    Ms. Hosley, welcome. Thank you for coming down from Rhode 
Island. Please present your statement.


    Ms. Hosley. Chairman Whitehouse, Senator Blumenthal, thank 
you for the opportunity to testify before you today on behalf 
of Rhode Island Student Assistance Services and the Jamestown 
and North Kingstown Substance Abuse Prevention Coalitions. I am 
pleased to provide you with our perspective on effective 
strategies for reducing the abuse, misuse diversion and fraud 
of prescription drugs.
    Rhode Island is a small State, but we seem to show up in 
the top of the national statistics when it comes to substance 
abuse. In 2004, the last year the National Survey on Drug Use 
and Health asked about the non-medical use of prescription 
drugs, Rhode Island was tied for fifth with two other States. 
In 2008, when the same survey asked about the use of pain 
relievers non-medically, Rhode Island came in seventh. It did 
not matter which of the five counties you looked at. They were 
all similar. The last Rhode Island SurveyWorks data showed that 
1 percent of high school students have tried painkillers 
without a doctor's prescription.
    I manage a drug-free communities grant in North Kingstown. 
Prior to this, I oversaw strategic prevention framework State 
incentive grants. In my 20 years of working in prevention, I 
had never seen such well-organized efforts as with these 
grants. After the first 3 years, we saw a drop in 30-day 
alcohol use of 14 percent and a 4-percent decrease in marijuana 
use among high school students. We had focused our efforts on 
underage drinking.
    We have cooperative relationships with multiple key 
partners which make it relatively easy to work on media 
campaigns, policy changes, law enforcement efforts, and more. 
The national prescription drug take-back program was held on 
April 30th in conjunction with the DEA. In North Kingstown, the 
local police department and the State police filled five boxes. 
When I received the list of how many pounds of drugs were 
collected, I saw that the top eight communities were either 
drug-free communities grantees or had the strategic prevention 
framework grant, or both. Together they had collected over 75 
percent of the 1,716 pounds of drugs. Cities and towns that 
have the funding can get citizens educated and involved. They 
get results.
    I used to be a student assistance counselor. Student 
assistance counselors are on the front lines. Unfortunately, 
Federal and State funding no longer covers the cost to ensure 
that minimum programs are funded, especially since the safe and 
drug-free schools and communities funding was eliminated. The 
Rhode Island Student Assistance Program is a key element in the 
prevention infrastructure since the counselors are insiders. 
Along with providing early intervention, they can also assist 
with evaluation, policy, and enforcement efforts in the 
    Last month, I heard the story of a student who barged into 
a student assistance counselor's office acting confused and 
incoherent. The counselor found out that she had taken 
prescription drugs that were not prescribed to her, along with 
LSD, and determined that she was in a drug-induced psychosis. 
The girl was taken to a hospital by ambulance where she stayed 
for 3 weeks. She is now back in school but needs to take 
lithium, which is usually prescribed for people with bipolar 
disorder, to remain stable enough to stay in school. She is 
still having crying bouts and difficulty handling stress. The 
boy who gave her the drugs has been released from prison and is 
allowed to attend school with an ankle monitor. Two lives 
connected by prescription drug abuse resulted in both having 
diminished chances for future success.
    While Rhode Island is just beginning to address the complex 
issues related to prescription drug abuse among teens, I 
believe one of our more effective prevention mechanisms will be 
the student assistance program. These highly trained counselors 
are onsite where access for students is easy and confidential. 
Collectively, the student assistance program, working in tandem 
with community coalitions, has been successful in reducing the 
use and abuse of alcohol and tobacco. I have every reason to 
believe that continuing and expanding the student assistance 
program, along with coalitions through the drug-free 
communities program, will help communities handle the 
complexity of prescription drug abuse among teens.
    I have provided more comprehensive recommendations in my 
written statement, but in the interest of time, I would like to 
focus on the one that is the most critical. I believe that with 
drug use on the rise and the elimination of the safe and drug-
free schools and communities program, the Federal Government 
should focus more emphasis and funding on community and school-
based substance abuse prevention and intervention strategies 
and programs by explicitly requiring that drug prevention and 
intervention programming be adequately included in the 
reauthorization of the Elementary and Secondary Education Act 
and by fully funding the drug-free communities program.
    We have the potential to reduce the abuse of prescription 
drugs among youth in schools and communities throughout Rhode 
Island as well as nationwide.
    Thank you for the opportunity to testify. I would be happy 
to answer any questions you may have.
    [The prepared statement of Ms. Hosley appears as a 
submission for the record.]
    Chairman Whitehouse. Thank you, Ms. Hosley.
    We will take Mr. Eadie's statement first, and then we can 
ask questions as a panel. But I wanted to thank you for the 
quality of your testimony. For those who have not read it but 
have just listened to you, you gave a summary today, but your 
full statement will be a part of the record, and it will be 
extremely helpful.
    I wanted to also mention, specifically with respect to the 
recommendation that this be protected in the reauthorization of 
the ESEA, Senator Brown, who was here, has a very keen interest 
in all of this and has--I guess he has rotated off the HELP 
Committee now. I am not on the HELP Committee. We will be doing 
that bill in that Committee. And Senator Blumenthal is on that 
Committee as well. So Senators who have been here today--I 
guess Senator Klobuchar is not, but you have very good 
representation of that Committee here by, I guess, fortuity. So 
it was a good recommendation for you to make at this moment.
    Mr. Eadie, please proceed.


    Mr. Eadie. Good morning, Chairman Whitehouse and Senator 
Blumenthal. Thank you for the opportunity to appear before you 
on behalf of the Center of Excellence for Prescription 
Monitoring Programs at Brandeis University. We thank you for 
the honor of testifying on this critical matter.
    The Center of Excellence seeks to help end the prescription 
drug abuse epidemic without compromising pain management or the 
legitimate prescribing of controlled substances. In 
collaboration with the Alliance of States with Prescription 
Monitoring Programs, the Center provides academically sound and 
practice-relevant information, evaluation, and expertise to 
prescription monitoring programs and other stakeholders. The 
center is funded by a grant from the Department of Justice 
Bureau of Justice Assistance.
    The urgency of our work is based upon our knowledge that: 
daily, 50 people in our Nation die from unintentional 
prescription opioid overdoses; and, daily, 20 times that number 
are admitted to hospital emergency departments for opioid 
    At the Center of Excellence, we believe that we must 
improve our methods for identifying and interdicting 
prescription opioid abuse in order to slow down and reverse 
this epidemic's ever rising toll.
    The rapid growth in States with prescription monitoring 
programs--and I am delighted to say that the number is now 48 
States. Five have just passed legislation in the last few 
weeks, and it has been signed. And we just have the District of 
Columbia and two States left--is a very hopeful accomplishment. 
The majority of these States have been authorized since 2003, 
when the Harold Rogers Prescription Drug Monitoring Programs 
Grant funding began--a program administered by the Department 
of Justice's Bureau of Justice Assistance. Through that 
program, competitive grants have stimulated growth and 
enhancements among the PMPs. Important additional funding has 
been provided by the NASPER program until this new budget. That 
program, administered by the Substance Abuse and Mental Health 
Services Administration, is a formula grant program that has 
been important in assisting States' prescription monitoring 
programs by supporting their operations.
    The continued operation of PMPs and the significant 
enhancements called for to address the prescription drug abuse 
epidemic appear to call for continuation and expansion of both 
unique programs.
    In addition to Federal funding support, we need a rapid 
evolution of the prescription monitoring programs into a new 
generation of even more effective systems, a new generation 
whose hallmark must become proactivity. The new generation will 
take advantage of technological advances and integrate them 
into the fabric of PMP operations. Many characteristics of the 
new generation are highlighted in the White House Office of 
National Drug Control Policy's new Prescription Drug Abuse 
Prevention Plan, which you have discussed previously.
    In addition, interstate PMP data sharing is essential. This 
must be completed in order to create a national network of 
State prescription monitoring programs that are interoperable 
through the Prescription Monitoring Information Exchange Hub, 
known as the PMIX Hub, which BJA, the IJSI Institute, and the 
Alliance of States with Prescription Monitoring Programs have 
been working to establish for 6 years with support from our 
center. The Hub is operational today, and several States are in 
process of interconnecting.
    In addition, we need to work on the following issues:
    We must increase the proactive reporting to prescribers 
across the Nation where PMPs analyze the data within their 
databases and send it out when they identify potential problems 
and let prescribers and, for that matter, pharmacists know what 
is going on.
    We also have other changes to make within the systems. You 
have touched on some of them already.
    Making data more timely. Oklahoma is pioneering such an 
effort today. Starting in April, they have got point-of-sale 
data going into their systems.
    Making access seamless, using electronic health records as 
a way of doing that.
    Combining prescription monitoring programs and e-
prescribing, which you have discussed, is an important element 
and a new element.
    Considering with public and private third-party payers the 
value of mandating prescribers to assess PMP data prior to 
issuing the first controlled substance prescription and 
periodically thereafter as a condition of payment.
    In addition, we need to increase the requested reports and 
proactive use of the data for pharmacies. We need to also 
develop a verification system that PMPs would carry out to tie 
to dispensing, to make sure that the requirements--for example, 
if there is mandatory physician education, the prescription 
monitoring program should assure that that is being 
accomplished, that prescribers who are not trained are not 
going to prescribe, or if they do, report effectively.
    We need to also--and I cannot emphasize this enough. We 
need to increase and improve the access that law enforcement 
agencies have to prescription monitoring program data, both in 
terms of solicited reports where they request reports and in 
terms of unsolicited reports where the PMPs proactively 
identify problems and send them out. The same thing is true for 
health professional licensing agencies.
    There are other users of PMP data who need to be involved 
that are not currently involved. Just as an example, the Indian 
Health Services, Veterans Administration, and Department of 
Defense health care systems need to be integrated. And I know 
you have talked about that already, but this system has to be 
beyond that because it is not just the integration of VA and 
Department of Defense. It is the access to the other 
prescriptions issued for the same individuals in those systems 
who may be going outside to get cash paid prescriptions, which 
compounds and confounds what is going on within the VA system 
or the Department of Defense, and they are blind to it at the 
    We need to develop an early warning system, and PMPs have 
the capability of doing just that.
    We need to develop greater concern for youth. Our initial 
analysis identified significant concerns there.
    And we need to talk about mandatory prescriber education. 
It is from my perspective exactly important, and I recommend it 
highly to you.
    [The prepared statement of Mr. Eadie appears as a 
submission for the record.]
    Chairman Whitehouse. Thank you, Mr. Eadie. I appreciate it. 
And thank you, Ms. Hosley.
    Your work in Rhode Island must have exposed you to some 
pretty well informed views about where it is that youngsters, 
in particular teenagers, are getting access to these 
prescription drugs. And if you could comment a little bit about 
that and particularly how some of the earlier testimony about 
the need to improve on the regime of disposal could help this, 
because as I understand it, throwing them down the drain risks 
creating environmental problems, leaving them in the cabinet 
risks creating abuse or encouraging abuse, and there really is 
no clear third option that most Rhode Islanders are aware of.
    Ms. Hosley. Well, as I wrote in my statement of record, 
students seem to know who are getting their wisdom teeth pulled 
and who might have access to painkillers especially. We hear 
that in schools kids have access to Adderall. So it seems to be 
something where the students may share the medications that 
they are prescribed, but also are getting it from medicine 
cabinets, from their parents and grandparents. I think just the 
fact that these prescriptions are overprescribed, they do tend 
to be sitting in people's homes.
    So I think that increasing awareness is huge, and when we 
had the take-back program, we made sure that we publicized it 
in the papers and that we put it on the list serves to go to 
home to all the parents so that they were aware that there was 
a way for them to get the medications to a place to properly 
dispose of them.
    I think the fact that they cannot just go at any time is a 
little difficult. I know I missed that date and still have some 
prescriptions sitting at home. But I heard that next year it 
might be twice in the next year. So at least if we had some 
type of mechanism in place for the disposal, that would help, 
but we really do need to increase the awareness.
    You know, with funding such as the drug-free communities, 
we can put a multi-pronged strategy in place for whichever drug 
we are focusing on, and I do not think we have really done that 
yet as far as prescription drugs go. It is something we need to 
do, but I think that all the communities need to do it and not 
just certain ones who are able to get additional funding.
    Chairman Whitehouse. We have the good fortune in Rhode 
Island to have one of the largest pharmacy companies in the 
country headquartered right in Woonsocket--CVS--and perhaps you 
and I could work together with them once the regulations are 
finally through their Federal administrative rulemaking 
process, either at the end of the year or early next year, as 
DEA Director Leonhart suggested, and work with them on perhaps 
taking a leadership role in this area. So I look forward to 
working with you on that.
    Mr. Eadie, the States tend to manage these prescription 
drug monitoring programs. There has been a relatively limited 
Federal role other than the grantmaking role. Interoperability 
has come up as an area where it might be suitable for the 
Federal Government to provide some support and some guidance to 
these State-based programs.
    It appears that their State base actually is an asset in 
terms of awareness of local conditions, comfort about privacy 
and security issues, and things like that. Without taking those 
elements away, without making this something other than the 
State-based program that it is and has been, are there other 
ways than the interoperability where you think that the Federal 
Government could have a helpful role in supporting and guiding 
what would remain under this model a State-driven prescription 
drug monitoring program?
    Mr. Eadie. Chairman Whitehouse, I think there is a role. I 
think that things we--in mandatory education, for example, if 
that is required, then it should be a corollary that 
prescription monitoring programs should build into their system 
an ability to track that and make sure that the trained 
physicians are the ones who are--and dentists, for that matter, 
and other prescribers, are the ones who are actually 
prescribing. That is a simple thing.
    Now, the larger question is how to involve the Federal 
Government without disrupting the value of the State-based 
systems, and the responsiveness that you have indicated is 
extremely important.
    Innovation is also important. Without State-run programs, 
we would not have the electronic prescription systems available 
to doctors today. That was an innovation that started with the 
State of Nevada just a little over a dozen years ago, and it is 
now widespread across the Nation. I mentioned Oklahoma as an 
example. They are starting point of sale. They are pioneering 
that effort.
    Massachusetts is pioneering efforts today for electronic 
health records integration. They also have an electronic-
prescribing system testing in western Massachusetts, which you 
may or may not be aware of, but it was approved with a waiver 
by the Drug Enforcement Administration. It is funded by the 
Administration for Health Research and Quality. It is a small-
scale project, but it has demonstrated that electronic 
prescribing by physicians can be operational and is effective, 
and that is ongoing today. It is actually operational at the 
moment. And we have been party to that and supporting that as 
it goes forward, and I think there is a major role for the 
future for that.
    I think that electronic prescribing should be integrated 
with PMPs. At the moment that is not possible because it does 
not exist. But it should be integrated as quickly as possible, 
and I think that Federal funding support, which indicates 
support for that initiative, is important.
    In short, I think that broad guidelines of criteria or of 
guidance are valuable. Being too specific at the Federal level, 
which is a tendency to anchor into Federal law or regulations 
specific things that States should do, will ossify the systems 
at a point today where the technology is rapidly evolving. We 
cannot afford to have anything that is rigid. But there can 
certainly be guidelines. There can certainly be statements of 
encouragement. There can be, in effect, minimal guidance such 
as States that are receiving Federal funding for PMPs should 
have built into them interoperability with them and other 
States. There should be or could be--the same thing as it 
relates to e-prescribing and other things--broad categories of 
requirements without specifics so that we can innovate, we can 
create, we can go forward.
    Chairman Whitehouse. OK. Well, we are certainly interested 
in that in Rhode Island because, as you know, we are one of the 
top e-prescribing States in the country.
    Mr. Eadie. Yes.
    Chairman Whitehouse. We sort of go back and forth with 
Massachusetts as to who claims to be No. 1.
    Mr. Eadie. Exactly.
    Chairman Whitehouse. And we are advanced enough in 
electronic health records that we are actually looking at a 
statutory health information exchange. And as we speak, data is 
actually flowing through something called Current Care in Rhode 
Island so that it is being populated automatically into 
electronic health records outside of a single corporation but 
across entities. So we look forward to working with you on 
those ideas, and I think if we can do that, then people who are 
at the front lines working with kids like Ms. Hosley will have 
an additional, as Senator Blumenthal said, tool in their 
    And with that, Senator Blumenthal.
    Senator Blumenthal. Thank you, Mr. Chairman, and thank you 
both for being here from Massachusetts and Rhode Island, and 
thank you both for your work in this area. And I hope that 
folks in Rhode Island know how active and aggressive Senator 
Whitehouse has been with his background in law enforcement, but 
also his leadership in really moving the Judiciary Committee to 
take cognizance and take action in this area.
    I want to ask you about some of the potential actions that 
drug companies themselves could take in the area of 
discouraging or stopping drug abuse, apart from improving the 
monitoring programs that exist in many States, particularly 
with respect to painkillers, whether there are actions that can 
be taken to provide for greater safeguards in these areas.
    As you well know, OxyContin has been a continuing problem, 
oxycodone. There was an action by the Department of Justice and 
States, including Connecticut while I was Attorney General, 
relating to OxyContin. And the failure of the company that 
produces it to really follow perhaps more responsible measures 
in the marketing and selling of the pills that were subject to 
pain release mechanisms. And I do not want to single out, 
because it would be unfair to do so, any one company, but I 
wonder if you could give us your observations as folks who are 
dealing firsthand, on the ground, in the trenches, with this 
problem about actions that you see the pharmaceutical drug 
companies themselves potentially taking to reduce this problem.
    Ms. Hosley. I am not sure whose responsibility it would be, 
but perhaps if a shorter timeframe was given when those 
prescriptions were prescribed so that they did not get a 30-day 
prescription for having their wisdom teeth removed and maybe 
had a 3-day with the option to renew. I think there is too much 
medication out there, and I think it is way beyond what needs 
to be out there, and that just invites the misuse and abuse of 
the drugs.
    Mr. Eadie. I would recommend great care in the way in which 
funding from the manufacturers might be considered. Perhaps in 
the prevention area, the substance abuse prevention area, it 
would be helpful for having funding available. It certainly is 
an area where they have a need to share responsibility for what 
has happened with the use of their drugs.
    When it comes to issues closer to regulatory activities and 
things like the prescription monitoring programs, I think that 
one has to be very careful about considering funding that is 
perhaps voluntary or so-called voluntary. I can give the 
example of our own situation at the Center of Excellence. We 
were approached by a major drug manufacturer in our first month 
of existence and asked if we would be willing to collect data 
from prescription monitoring programs and provide it to them 
for their RIMS obligation as it related to a new product they 
were bringing on the market, a new controlled substance 
product. And we thought about it carefully and decided that we 
could not do that in good faith because, No. 1, there would be 
the appearance perhaps of conflict of interest on our part to 
do that; and second would be the potential reality of it--that 
is, there would be no way we could look at the data without 
knowing somewhere in the back of our minds that how we analyzed 
the data, the way we presented it, the kinds of charts we 
produced, the analysis we stated, all could be inadvertently 
influenced by our knowledge that future funding would rest on 
how happy that manufacturer would be with the reports we 
    When we said no, thanked them, they came back with a 
counter proposal that we then serve in that capacity with 21 
drug manufacturers, the ones working with the FDA on the RIMS 
project for the class-wide RIMS for the extended-release 
opioids. And we thought about that again. There was great value 
in collecting the data from the States. We still want to do 
that. It is very important to collect the data and analyze it. 
We know that from experience. But once again, the two caveats 
that I mentioned a moment ago came back to our cognitive 
function as we thought about it very carefully, and we thought 
about how easily a word change can be made in a document from a 
word that is choice of phrase, choice of how things are 
presented, there would be no way that we could protect 
ourselves against the thought in the back of our minds that 
next year's money would be dependent on how happy these 
manufacturers are with what we produce. And so we ultimately 
thanked them but said no.
    Having said that, I think that applies generally across the 
board to any of the prescription monitoring program activities 
that States are involved with. I honor what the Florida State 
Legislature has just done in passing a law that refuses to 
allow their prescription monitoring program to accept funds 
from drug manufacturers, either directly or indirectly. I think 
that was a major step forward. As you probably know, there was 
$1 million offered to them by a drug manufacturer. But let me 
give you examples.
    We know that there are drug manufacturers that have been 
very active in supporting prescription monitoring programs for 
the last decade. But if you read their materials very 
carefully, there is no provision within that for the kind of 
proactive analysis of data and distribution of that data that 
is absolutely essential for prescription monitoring programs to 
go forward, particularly as it relates to law enforcement. And 
there is also--there has been in recent years a number of 
States that have enacted laws that have provided restrictions 
on law enforcement that extend to requiring court orders, 
requiring subpoenas, requiring a variety of what amount to, in 
our view, inappropriate restrictions on law enforcement's 
access to the data.
    And so I think that there is room for manufacturers on the 
other hand to contribute to a fund that might be 
Congressionally mandated like the Food and Drug Administration 
establishes a fund that pays for its costs and which 
manufacturers are mandated to contribute to that fund, and the 
fund is then used to cover the costs of the FDA in reviewing 
and approving their drugs.
    Why couldn't, why shouldn't there be an equivalent fund 
established by mandate of the Federal Congress to drug 
manufacturers to contribute significantly to the funds 
necessary to operate these prescription monitoring programs? 
They benefit by it extraordinarily. There is no reason why they 
cannot and should not contribute to the solution to the 
problems created by their drugs.
    Senator Blumenthal. Well, I thank you for that answer. My 
time is up, but I look forward to working with both of you, and 
I want to say that the maker of OxyContin, by the way, has 
taken some very responsible steps. Purdue Pharma has taken some 
very important leadership steps in reason to these problems. 
And one area where I was thinking more could be done is in 
providing warnings, perhaps in restricting the length or amount 
of prescriptions as you have suggested, Ms. Hosley. But I look 
forward to working with you, and, again, thank you, Mr. 
Chairman, for your work in this area.
    Chairman Whitehouse. Thank you, Senator Blumenthal.
    Let me thank my colleagues Senator Brown, Senator 
Klobuchar, and Senator Blumenthal all for participating in this 
hearing and, I guess, wrap up by saying how impressed I think 
we all have been by the information that we've heard today 
about the epidemic nature of the prescription drug problem and 
the rapid rate at which it is growing and affecting our 
emergency rooms, affecting our families, affecting our schools, 
affecting our communities. The areas that appear to need 
further attention and effort include public awareness, and I 
was glad that the Director of the Office of National Drug 
Control Policy, Director Kerlikowske, was here to talk about 
his efforts in that regard.
    We appear to need to better coordinate our law enforcement 
resources, although it does appear that the prescription drug 
monitoring programs stand out as a growing and effective State-
based vehicle for addressing this problem, but one that could 
be strengthened with further integration with electronic 
prescribing, further integration with electronic health 
records, some integration, beginning integration with the VA, 
Department of Defense, and Indian Affairs health systems, and 
improved interoperability State to State. So those seem to be 
worthy goals that come out of this hearing.
    The last is that we do not seem to be in a very good place 
yet with respect to the disposal of unused controlled 
pharmaceuticals, that throwing them down the drain creates one 
set of problems, leaving them in the cabinet creates another 
set of problems. And we have not really developed a robust 
system for finding other ways to dispose of them, and we look 
forward to working particularly with the pharmacy and 
pharmaceutical industry to come up with solutions since it is 
their product that ultimately is at the heart of this problem.
    So I appreciate Director Kerlikowske and Director Leonhart 
for taking their time and sharing with us their expertise this 
morning. I appreciate very much Ms. Hosley's testimony and her 
work in Rhode Island on the ground with the kids who are at the 
center of our attention really today, and Mr. Eadie for your 
many years of service. I think that you are sort of the father 
or uncle, or whatever you would call it, of the PDMP movement, 
and clearly it is one of the success stories that we want to 
build on as we continue to move forward and address this 
    We will keep the record of this hearing open for an 
additional 7 days, an additional week, if anybody wishes to add 
anything to the record. And other than that, the hearing will 
adjourn, and thank you very much for your testimony.
    [Whereupon, at 10:31 a.m., the Subcommittee was adjourned.]
    [Questions and answers and submissions follow.]

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